Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study

Fondazione Policlinico Universitario Campus Bio-Medico1 site in 1 country13 target enrollmentJuly 1, 2023

ConditionsSarcoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sarcoma
Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Enrollment: 13
Locations: 1
Primary Endpoint: Improvement in the Toronto Extremity Salvage Score (TESS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.

Primary objectives:

Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;
Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;
Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).

Secondary endpoints will be:

the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);

• The change in walking performance before and after the rehabilitation treatment.

Registry

clinicaltrials.gov

Start Date

July 1, 2023

End Date

July 1, 2026

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Responsible Party

Principal Investigator

Sergio Valeri

Principal Investigator

Fondazione Policlinico Universitario Campus Bio-Medico

Eligibility Criteria

Inclusion Criteria

•Adult patients affected by primary localized soft tissue sarcoma, candidate to limb/trunk surgery with wide excision or retroperitoneal resection (including resection of the iliopsoas muscle with possible damage to the femoral nerve) with curative intent.

Exclusion Criteria

•Patients with recurrent tumors;
•patients with metastatic disease;
•patients with palliative surgery;
•patients with amputations.

Outcomes

Primary Outcomes

Improvement in the Toronto Extremity Salvage Score (TESS)

Time Frame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

a change in the TESS greater than 7 points

Secondary Outcomes

Pain evaluation(T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery))
Motor performance evaluation(T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery))
Evaluation of Quality of Life(T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery))